FDA
The DC-based biopharma disputed the FDA’s conclusions regarding the data provided in its supplemental application for Hetlioz and promised to keep pushing for an approval.
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Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s approach to pre-approval inspections.
With notable therapies from Biogen, Sarepta and MacroGenics failing to show efficacy in pivotal or confirmatory trials, experts question the use of biomarker evidence for approval while one former regulator insists that a “failed trial is not a failed drug.”
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Shares of Supernus Pharmaceuticals were climbing in premarket trading this morning after Friday’s announcement the U.S. FDA approved the company’s non-stimulant treatment for ADHD in pediatric patients 6 to 17 years of age.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
This morning, Janssen announced Ponvory has been greenlit as the only oral disease-modifying therapy studied against an established oral comparator for this indication.
The approval was for Arcalyst (rilonacept), a weekly, subcutaneously-injected, recombinant fusion protein that blocks interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) signaling.
The drug is a lipoglycopeptide antibiotic. It is given in a single, one-hour infusion.
EmpowerDX, a Eurofins subsidiary, just launched its direct-to-consumer COVID-19 Home Collection Kit in the U.S. through Amazon, making it one of a miniscule number of at-home and over-the-counter kits that are putting detection of the SARS-CoV-2 virus in the hands of patients.
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.